Clinical Effectiveness of Training for Awareness Resilience and Action (TARA) Compared to Standard Treatment for Adolescents and Young Adults With Depression, a Pragmatic Multi-center Randomised Controlled Superiority-trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 136
- 试验地点
- 5
- 主要终点
- Reynold's Adolescent Depression Scale 2nd edition
研究概览
简要总结
Depressive Disorders constitute an increasing global health concern and available treatments for young people have not been sufficiently effective in haltering this trend. The novel group treatment program "Training for Awareness, Resilience, and Action" (TARA) was developed to target specific mechanisms based on neuroscientific findings in adolescent depression. TARA is framed within the National Institute of Mental Health's Research Domain Criteria and has documented feasibility and preliminary efficacy in adolescents with depression.
In this study, young people (age: 15-22) with depression will be recruited from specialized Child and Adolescent Psychiatry and Youth Clinics and randomized to receive either TARA or Standard Treatment (ST) until n=67 is reached in each arm. Outcome measures will be obtained before randomization (T0), 6 weeks after treatment start (T0.5), at 3- and 6 months follow-up (T1, T2). The primary outcome measure is Reynold's Adolescent Depression Scale (RADS-2) score at T1. Secondary outcome measures are RADS-2-score at T2, clinician depression rating with Children's Depression Rating Scale, Revised at T1,and self-rated anxiety with Multidimensional Anxiety Scale for Children, 2nd ed. at T1 and T2.
Other outcomes include heart rate variability and systemic bioindicators for depression from blood and hair. Data collected from subgroups within the study will include: brain magnetic resonance imaging and accelerometry. Qualitative interviews will be performed to reach a more comprehensive understanding of the subjective experience of being depressed and to what extent treatment adequately addresses this experience. A 2-year follow-up (T3) will be performed and presented separately.
The study will be the first Randomized Controlled Trial to examine the clinical effectiveness of TARA compared to ST for young people with depression. The investigators hypothesize that (1) TARA will result in greater reduction of depression symptoms compared to ST and that group differences will be maintained or increased at T2, (2) the treatment effect of TARA will be mediated by improved emotion regulation, sleep, and psychological flexibility, (3) bioindicators for depression will improve more in the TARA-arm compared to the ST-arm, (4) it will be possible/meaningful to explore the contextual factors perceived to drive the depression onset and maintenance, and the extent to which the different treatments address these factors.
详细描述
The primary aim of this study is to investigate the clinical effectiveness of TARA in treating depression in adolescents and young adults by using a Randomized Controlled Trial (RCT)-design, with an active control group based on standard treatment (ST) for depression in Child and Adolescent Psychiatry (CAP) and Youth Clinics (YC). Secondary aims are: 1. to identify potential mediating effects of improved emotion regulation, sleep and psychological flexibility on the treatment effect of TARA, 2. Investigate the effects the two treatment-arms on bioindicators for depression, 3. Increase the understanding of the subjective experience of depression onset and to what extent the treatments addressed what is perceived to drive the onset and maintenance of depression.
The study is designed as a partially nested multicenter parallel-group RCT with two treatment arms: 1) TARA and 2) ST, including but not limited to anti-depressive medication such as selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy. Participants are randomized to one of the two treatment arms, both delivered via the local CAP and YC unit where the participants are being either referred to, are wait-listed or treated. The study is planned in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and will be analyzed and reported in accordance with the recommendations in consolidated standards of reporting trials (CONSORT).
Participants and procedures
Recruitment, treatment and data collection will be conducted in three cities in Northern Sweden, each with 1-2 centers. Several centers will be included step-wise in the RCT, until a sufficient recruitment capacity has been reached. Before including a new center the implementation of Good Clinical Practice-guide-lines, a clinical research infrastructure and the training of study-staff must be satisfactory and a pilot trial will have been conducted at each site to show feasibility. The investigators intend to recruit participants from the Child- and adolescent psychiatry (CAP) specialized outpatient academic unit and the youth outpatient community clinic (YC) in the university city Umeå (population 89 000), CAP and YC in Skellefteå (population 36 000) and CAP in Örnsköldsvik (population 33 000). The CAP unit in Sundsvall (population 55 000) is also prepared for participation, this center will be activated only if needed to maintain recruitment pace. Depending on the general recruitment rate and the feasibility of implementation of the study protocol at the different sites, one or several of the sites may be omitted.
Adolescents and young adults (15-22 years of age) with depression will be recruited to the RCT. In this study depression is defined as having a diagnosis of major depressive disorder (MDD) or persistent depressive disorder (PDD) according to DSM 5 (dysthymia in DSM-IV) or a clinician depression rating >40 using Children's Depression Rating Scale - Revised (CDRS-R). The recruitment is done through three possible pathways: 1) at the time of an incoming referral, 2) by clinical staff who recruit potential participants at their first clinical visit, from those wait-listed for treatment, or during ongoing standard treatment and 3) by participants responding to flyers posted in the local waiting-rooms and at the student health clinic at the University of Umeå.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient at the CAP or YC unit
- •The criteria for a diagnosis Major Depressive Disorder (MDD) or Persistent Depressive disorder (PDD)/dysthymia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or 5 are fulfilled. The clinical diagnosis will be validated during the screening process using the Mini International Neuropsychiatric Interview (M.I.N.I.)/Mini-International Neuropsychiatric Interview for Children and Adolescents (M.I.N.I-kid). If a diagnosis of MDD or PDD/dysthymia is not conclusive a cut-off of 40 or above on the Children's' Depression Rating Scale - Revised will be used for inclusion.
- •For patients in specialist child- and adolescent psychiatry clinics below the age of 18 one parent/ legal guardian must be available and agree to participate in parts of the sessions in case the individual is randomized to the TARA-arm.
排除标准
- •One or several severe psychiatric co-morbid diagnoses that may interfere with or hinder group participation, including: intellectual development disorder, severe autism spectrum disorder, psychotic disorder, bipolar disorder, severe anorexia nervosa, substance use disorders, acute posttraumatic stress disorder (PTSD) and severe dissociative syndromes.
- •One or several psychiatric symptoms or behavioral problems that may interfere with or hinder group participation including:
- •Severe self-harming behavior
- •Acute suicidality, including a reported suicide attempt in the last 6 months or hospitalization for suicidality in the last 6 months
- •Disabling dissociative symptoms or > 6 points as mean item score on the Adolescent Dissociative Experiencing Scale.
- •Frequent use of recreational drugs (a urine drug screen will be performed at baseline and if positive a second test has to be negative for inclusion)
- •Reports of manic or hypomanic symptoms during the last year
- •A first degree relative with bipolar disorder (a first episode of MDD may be an incipient bipolar disorder which is not the treatment target for TARA).
- •On-going trauma, neglect, abuse or domestic violence or destabilizing legal process.
- •Non-fluency in oral and written Swedish since the TARA groups are held in Swedish and assessment forms are in Swedish
- •Other psychiatric comorbidities such as attention deficit hyperactivity disorder (ADHD), anxiety, high functioning autism spectrum disorder and mild to moderate eating disorders are not considered exclusion criteria.
- •Accidental findings of biochemical anomalies will not be considered exclusion criteria and medical conditions will be referred for appropriate treatment.
结局指标
主要结局
Reynold's Adolescent Depression Scale 2nd edition
时间窗: 3 month follow-up
Self report. Total raw-score. Raw score range is 30-120 and higher scores mean a worse outcome.
次要结局
- Children's Depression Rating Scale - Revised(3 month follow-up)
- Multidimensional Anxiety Scale for Children(3 month follow-up and 6 month follow-up)
- Reynold's Adolescent Depression Scale 2nd edition(6 month follow-up)